Disposable diagnostic device and method

• US 6,426,230 B1
• Filed: 08/01/1997
• Issued: 07/30/2002
• Est. Priority Date: 08/01/1997
• Status: Expired due to Term

• Current Assignee: Qualigen, Inc.
• Original Assignee: Qualigen, Inc.
• Inventors: Feistel, Christopher C.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/905,261
• Time in Patent Office: 1,824 Days
• Field of Search: 422/58, 422/61, 422/100, 422/102, 422/103, 436/164-166, 436/176-180, 436/808
• US Class Current: 436/165
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/0621 Control of the sequence of chambers filled or emptied
• CPC Class Codes: B01L 2200/0668 Trapping microscopic beads
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/16 Reagents, handling or storing thereof
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0457 passive flow or gravitation
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 3/50273 characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/505 flexible containers not provided for above
• CPC Class Codes: G01N 33/54386 Analytical elements

Abstract

Disclosed is a disposable diagnostic device for conducting a diagnostic test on a sample. The device includes a substantially planar, flexible article, a channel formed within the article, at least one fluid-receiving compartment formed within the article and fluidly connectable to the channel, and a solid phase movably positioned within the channel. The article may be a laminate, and in particular, a laminate formed from two substantially planar, flexible sheets laminated together.

Claims

1. A method of manipulating a container, comprising:

providing a container having a reaction channel fluidly coupled to a plurality of compartments, including a sample receiving compartment and a signal detection compartment, wherein at least one of the compartments includes a reagent;

introducing a sample into the sample receiving compartment;

contacting a first portion of a surface of the container with a device having a plurality of independently operable actuators, wherein at least one of the actuators compresses a portion of the container thereby moving at least part of the sample into the reaction channel;

contacting a second portion of the surface of the container with another one of the actuators that compresses a portion of the container thereby preventing a movement of at least one of the part of the sample and the reagent between at least two of the plurality of compartments; and

moving the part of the sample in at least one of a unidirectional and bi-directional movement between the sample receiving compartment and the sample detection compartment using the plurality of actuators.

2. The method of claim 1, wherein the container has a flexible top sheet and a flexible bottom sheet, and wherein at least one of the compartments is formed by the flexible top sheet and bottom sheet.

3. The method of claim 1 further comprising aliquoting the sample.

4. The method of claim 1, wherein the sample comprises an analyte and reagent that has a substantially selective binding towards the analytc.

5. The method of claim 1, wherein the reagent is selected from the group consisting of a fluorescent marker, a calorimetric marker, a chemiluminescent marker, an enzymatic marker, and a radioactive marker.

6. The method of claim 1 further comprising providing the container with a waste fluid compartment.

7. The method of claim 6 further comprising providing the container with a second waste fluid compartment.

8. The method of claim 1 further comprising providing the container with a wash supply compartment.

9. The method of claim 1 further comprising detecting a signal in the sample detection compartment.

10. The method of claim 1 further comprising providing the device with a signal detector, and detecting a signal using the signal detector.

11. The method of claim 10 wherein the signal detector comprises a photomultiplier tube.

12. The method of claim 1 further comprising providing a solid phase in the reaction channel.

13. The method of claim 12 wherein the solid phase further comprises an antibody.

14. The method of claim 12 wherein the solid phase further comprises an antigen.

15. The method of claim 12 further comprising combining the solid phase and the sample, and agitating the solid phase by bidirectionally moving the solid phase using the actuators.